FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
Regulatory approval: On March 25, 2026, the FDA approved relacorilant (Lifyorli), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1–3 prior systemic regimens, including at least one with bevacizumab. Approval was supported by the phase 3 ROSELLA trial, which showed improved PFS and OS versus nab-paclitaxel alone. Labeling includes specific contraindications and safety warnings.
FDA approval (March 25, 2026)
The FDA approved relacorilant (Lifyorli; Corcept Therapeutics), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1–3 prior systemic treatment regimens, including ≥1 regimen with bevacizumab.
Supporting evidence: ROSELLA (NCT05257408)
ROSELLA was a multicenter, open-label trial in 381 patients. Prior bevacizumab was required; patients could have received up to three prior systemic lines. Patients requiring chronic or frequent glucocorticoids were excluded. Randomization was 1:1 to relacorilant + nab-paclitaxel vs nab-paclitaxel alone.
Primary efficacy measures: PFS (blinded independent central review; RECIST v1.1) and OS.
- Median PFS: 6.5 vs 5.5 months (HR 0.70, 95% CI 0.54–0.91; p=0.0076)
- Median OS: 16.0 vs 11.9 months (HR 0.65, 95% CI 0.51–0.83; p=0.0004)
Key safety/labeling notes
Contraindication: patients who require corticosteroids for a lifesaving indication. Warnings include neutropenia/severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity. Common adverse reactions (≥20%) included decreased hemoglobin/neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.
Recommended dosing (label)
Relacorilant 150 mg orally on the day before, of, and after each nab-paclitaxel infusion; nab-paclitaxel 80 mg/m² IV on days 1, 8, 15 of each 28-day cycle, until progression or unacceptable toxicity.